NCT03033628

Brief Summary

The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

January 22, 2017

Last Update Submit

February 14, 2017

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

  • pain during injection

    pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.

    within 1 year

Study Arms (2)

DV group

EXPERIMENTAL

Device: injection using DentalVibe comfort system. giving maxillary infiltration dental local anesthesia with the aid of "DentalVibe comfort system" on one side of the maxillary arch prior extraction of primary molar tooth

Device: injection using DentalVibe comfort system

C group

ACTIVE COMPARATOR

Device: traditional dental injection giving maxillary infiltration dental local anesthesia without the aid of "DentalVibe comfort system" on the other side of the maxillary arch prior extraction of primary molar tooth

Device: traditional dental injection

Interventions

injection using DentalVibe comfort systemDEVICE

giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.

DV group
traditional dental injectionDEVICE

giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.

C group

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children aged 6-7 years old.
  • Apparently healthy Children.
  • Cooperative children.
  • Children with carious maxillary bilateral primary molars indicated for extraction.

You may not qualify if:

  • Children who are allergic to amide group.
  • Children with Neurologic disorders.
  • Children with mental disability.
  • Presence of periapical or gingival legion.
  • Severe Gingivitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Norhan El-dokky, PHD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Muaaz Hilal, DR

CONTACT

00201226090374muaaz09@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 22, 2017

First Posted

January 27, 2017

Study Start

April 1, 2017

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

February 15, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share